Safety study of efgartigimod in adults with myasthenia gravis
Observes safety of efgartigimod in adults with generalized myasthenia gravis who take it.
Key facts
- Who runs it
- argenx
- Where
- Bergamo, Bologna, Naples, Pisa, and Roma, ItalySee the 5 sitesAlso in 5 other countries, 30 sites
- Trial code
- Registry title
- A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
- Status
- Recruiting
- People taking part
- 680 people, planned
- Started
- 4 Nov 2024
- Expected to end
- Jun 2034
- Type of study
- Observational, 2 groups
- Treatments tested
- efgartigimod
- Record updated
- 17 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with generalised myasthenia gravis (gMG). Some will start or have just started efgartigimod. Others have not taken it and are not planned to.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Diagnosed with gMG
- Earlier treatment
- One group is about to start efgartigimod or is in its first cycle. The other group has never taken efgartigimod and is not planned to start it.
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment
- Have provided appropriate written informed consent
Who cannot take part
- None
Where in Italy
Also in 5 other countries, 30 sites
- Piazza OMS - Organizzazione Mondiale della SanitàBergamo, ItalyContact: Manlio Sgarzi, MDTaking people
- Ospedale Bellaria - Clinica NeurologicaBologna, ItalyContact: Maria Pia Giannoccaro, MDTaking people
- Azienda Ospedaliera di Rilievo Nazionale CardarelliNaples, ItalyContact: Francesco Habetswallner, MDTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyContact: Michelangelo Maestri Tassoni, MDTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyContact: Raffaele Iorio, MDTaking people
About the trial
What the trial wants to find out
This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.
The 2 groups in the trial
- efgartigimod cohort
patients treated with efgartigimod
Treatment: efgartigimod
- non-efgartigimod cohort
patient treated with other MG medication
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
- Plain-language title
- Safety study of efgartigimod in adults with myasthenia gravisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 February 2026